# K061741: Mac-Lab/Cardiolab /Combolab/Specialslab System

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 15, 2006 after 87 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001305 (2000). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050093: Mac-Lab/Cardiolab EP/Combolab System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Most influential descendants
- K111200: Mac-Lab System, Cardiolab System, Combolab System, Specialslab System (2011), 8 descendants of its own
- K130626: Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic and Electrophys (2013), 7 descendants of its own
- K082421: Heartsuite Hemodynamics 7.10 (2008), 2 descendants of its own
- K213972: Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX (2022), 1 descendant of its own
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (2017), 1 descendant of its own

## Indications for use
Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO₂), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities. Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.) CardioLab System: The CardioLab System is intended to acquire, filter, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardiac signals, temperature, EtCO2 and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic). The CardioLab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities. Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.) ComboLab System: The ComboLab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time. SpecialsLab System: The SpecialsLab is the same as the Mac-Lab, CardioLab or ComboLab systems. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab, CardioLab or ComboLab.

Source page: https://510kreport.com/device/K061741
Methodology: https://510kreport.com/methodology